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Does Graft Improves the Outcome TIP Repair for Primary Distal Hypospadias?

Does Preputial Inlay Graft Improves the Outcome of Tubularized Incised Plate Repair for Primary Distal Hypospadias? a Prospective Randomized Controlled Trial.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05528276
Enrollment
25
Registered
2022-09-06
Start date
2022-08-29
Completion date
2024-10-29
Last updated
2022-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Penile Hypospadias

Brief summary

Hypospadias is a common congenital anomalies in male children affecting 1 in 200-300 male births, the penis urethral opening is found ventrally, penile curvature and a lack of foreskin (1). Multiple operations are described , Tubularised incised-plate is the preferred option for distal hypospadias and with trial to extend the operation indication to proximal and redo hypospadias (2). Its simple operative technique made TIP repair gain worldwide acceptance in addition to the low complication rate & good cosmetic outcome (3).It has several complication as stenosis meatus, fistula formation , uretheral stricture and failed repair (4). Objective scoring systems were introduced to allow better judgment and identification of the postoperative results, depending on pre-operative and intra-operative criteria (5). Modifications of the T.I.P operation was done to reduce complication and allow better results by using a graft , Snodgraft vs Snodgrass operation are nearly equal regarding the outcomes (6). To our knowledge there is no definite recommendation.

Interventions

PROCEDURERepair surgery

1. a circumscribing skin incision was made 2 mm below the hypospadias meatus, 2. penile degloving, 3. the para-urethral plate incision was made, 4. A vertical midline incision of the urethral plate was made from within the hypospadiac meatus and extended up to the mid-glans. 5. The urethral plate was tubularised, beginning proximally, and closed in two layers using 6/0 polyglactin 910 suture. 6. The neomeatus was formed on a catheter 2 F larger than the urethral stent. 7. A flap was harvested from the prepuce to cover the neourethra and finally glanuloplasty. 8. A suitable urethral stent was left in situ for 7-10 days, with a compressive dressing applied. * Grafted tubularised incised-plate . 1.Same steps but adding a graft (dorsal inlay) , 2. The graft will be taken from the inner preputial skin . 3. The graft will be sutured to overlying plate incision line from the old meatus to the tip of the glans.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
1 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

1. Children age more than 12 months to 12 years. 2. De-novo penile hypospadias after degloving of penis intraoperative (fresh, not previously operated)

Exclusion criteria

1. Circumcised 2. Ventral Penile curvature ≥30° after penile degloving & artificial erection, (requiring transection of urethral plate). 3. Uretheral plate less than 6mm 4. Megameatus intact prepuce 5. Albumin less than 3.5 g/dL

Design outcomes

Primary

MeasureTime frameDescription
Operation time.intraoperativethe duration of the operation will be measured from the start of anesthesia to end.
blood loss.one hour postoperativelythe amount of blood loss will be measured by CBC
site of the meatus6 months from the operationthe meatal position will be measured in centimeters from the original position .

Countries

Egypt

Contacts

Primary Contactabdelrahman M abdelkader
abdelrahmanmohamed.aa@gmail.com01068336396

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026